Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems CorporationThe Aplio a550, a450, and a Diagnostic Ultrasound Systems from Canon Medical Systems Corporation provide high-quality ultrasound images in various modes including 2D, Doppler, Color Doppler, Elastography, and 3D/4D imaging. These systems support advanced features enhanced by artificial intelligence and machine learning to assist clinicians in diagnostics across multiple clinical applications such as fetal, abdominal, cardiac, vascular, musculoskeletal, and more.
Intended Use
The Diagnostic Ultrasound System Aplio a550, Aplio a450 and Aplio a are indicated for visualization of structures and dynamic processes within the human body using ultrasound and to provide image information for diagnosis across a broad range of clinical applications including fetal, abdominal, intra-operative, pediatric, small organs, cardiac, vascular, musculoskeletal, laparoscopic and thoracic/pleural.
Technology
The device employs a wide array of probes with frequencies from approximately 2 MHz to 20 MHz, supporting multiple imaging modes such as B-mode (2D), M-mode, Color Doppler, blood-flow spectrum Doppler modes, shear wave elastography, 3D/4D imaging, smart navigation, fusion, and AI/ML-supported automated features like initial contour tracing and auto ejection fraction measurement.
Performance
Performance testing included risk analysis, verification and validation activities, bench testing with phantoms and volunteer data, and software validation, demonstrating that the device meets established specifications and performs as intended. No clinical studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2021
6 months - 2
FDA Approval
3/22/2022
Other devices from Canon Medical Systems Corporation
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